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The Death of Arcoxia: Drug Regulation in a "Whistleblower" Climate

This article was originally published in RPM Report

Executive Summary

There may not be a worse time to push a new drug through FDA-especially a "me-too" product with a questionable benefit-risk profile. Until Congress releases its grasp on the approval process, FDA isn't taking any chances. Unfortunately for industry, a few drugs are getting caught in the crossfire. Merck seemed unprepared for the new climate with Arcoxia; will other sponsors learn the lesson?

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